{"active_ingredient":["Active ingredient Carbamide Peroxide 6.5%"],"ask_doctor":["Ask a doctor before use if you have ▪ ear drainage or discharge ▪ ear pain ▪ irritation or rash in the ear ▪ dizziness ▪ an injury or perforation (hole) of the eardrum ▪ recently had ear surgery"],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY. ▪ Adults and children over 12 years of age: ▪ tilt head sideways ▪ place 5 to 10 drops into ear canal. ▪ tip of applicator should not enter ear canal. ▪ keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. ▪ use twice daily for up to four days if needed, or as directed by a doctor. ▪ any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor."],"effective_time":"20241028","id":"bbd28093-02a5-4201-abf5-13670eac97e4","inactive_ingredient":["Inactive ingredients adipic acid, anhydrous glycerin, polysorbate 80."],"indications_and_usage":["Uses For occasional use as an aid to soften, loosen and remove excessive ear wax"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222)."],"openfda":{"application_number":["M022"],"brand_name":["Ear Wax Removal Aid Drops"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["PHARMACY VALUE ALLIANCE, LLC"],"package_ndc":["68016-793-15"],"product_ndc":["68016-793"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["bbd28093-02a5-4201-abf5-13670eac97e4"],"spl_set_id":["85ae80c1-2bc2-4c90-9559-63510d03e739"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0840986035500"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Premier Value® NDC 68016-793-15 *COMPARE TO THE ACTIVE INGREDIENT IN DEBROX ® DROPS EAR WAX REMOVAL AID DROPS KIT Carbamide Peroxide 6.5% Ear Wax Removal Aid • Safe & Gentle • Microfoam Cleansing Action • Easy to use Instructions NET WT 0.5 FL OZ (15 mL) This kit include soft rubber bulb ear syringe and drops TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN IMPORTANT: Keep the carton for future reference on full labeling. Distributed BY: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox ® Drops. Eaxr Wax Removal Aid Drops Carbamide Peroxide"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"85ae80c1-2bc2-4c90-9559-63510d03e739","spl_product_data_elements":["Ear Wax Removal Aid Drops Carbamide peroxide CARBAMIDE PEROXIDE HYDROGEN PEROXIDE ADIPIC ACID GLYCERIN POLYSORBATE 80"],"spl_unclassified_section":["Other information ▪ Store at room temperature ▪ Avoid exposing bottle to excessive heat and direct sunlight ▪ Store bottle in the outer carton ▪ Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound. ▪ Keep cap on bottle when not in use"],"stop_use":["Stop use and ask a doctor if ▪ you need to use for more than four days ▪ excessive ear wax remains after use this product"],"version":"6","warnings":["Warnings Ask a doctor before use if you have ▪ ear drainage or discharge ▪ ear pain ▪ irritation or rash in the ear ▪ dizziness ▪ an injury or perforation (hole) of the eardrum ▪ recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if ▪ you need to use for more than four days ▪ excessive ear wax remains after use this product Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222)."],"when_using":["When using this product avoid contact with the eyes"]}